DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS— 510(k) K021539

Substantially Equivalent

Creative Contract (M) Sdn Bhd

FDA 510(k) clearance K021539 for DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS, Substantially Equivalent on 2003-03-05. Applicant: Creative Contract (M) Sdn Bhd.

Clearance details

Applicant: Creative Contract (M) Sdn Bhd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2002-05-10
Decision date: 2003-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sand Springs, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.